Cleared Traditional

Mbrace Cable

K232733 · Medacta International S.A. · Orthopedic
May 2024
Decision
239d
Days
Class 2
Risk

About This 510(k) Submission

K232733 is an FDA 510(k) clearance for the Mbrace Cable, a Cerclage, Fixation (Class II — Special Controls, product code JDQ), submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on May 3, 2024, 239 days after receiving the submission on September 7, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number K232733 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2023
Decision Date May 03, 2024
Days to Decision 239 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDQ — Cerclage, Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3010

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